CompletedNot Applicable

ENGAGE: Virtual Reality-based Psychotherapy for Negative Symptoms in Schizophrenia

Denmark30 participantsStarted 2024-12-09

Plain-language summary

The primary goal of this pilot study is to examine the feasibility and acceptability of a new Virtual Reality-based intervention against negative symptoms in schizophrenia spectrum disorders (SSD). The main questions it aims to answer are: 1. Is Virtual Reality-based therapy a feasible and acceptable treatment for negative symptoms in SSD? 2. Are there indications that the treatment is effective in reducing negative symptoms, improving daily functioning, and enhancing quality of life? Researchers will compare the new Virtual Reality-based treatment to standard psychiatric care to evaluate therapy effectiveness. Participants will be allocated to receive either 10 sessions of Virtual Reality-based therapy or Treatment as usual. All participants will undergo a thorough assessment at baseline and at follow-up after 12 weeks.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * ICD-10 diagnosis of a schizophrenia-spectrum disorder (F2x) * Negative symptom score of ≥3 on the SANS items avolition or anhedonia Exclusion Criteria: * Diagnosis of organic brain disease * Intellectual disability (IQ \< 70) * Current diagnosis of drug dependency * Command of spoken Danish or English inadequate for engaging in therapy * Refusing to be informed on incidental findings on the MRI scans

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility and acceptability as assessed by recruitment rate

Timeframe: Recruitment rate is monitored throughout the study period (15 months)

Feasibility and acceptibility as assessed by retention rate

Timeframe: Retention rates are monitored throughout the study period (15 months)

Feasibility and acceptability as assessed by level of satisfaction in the experimental group

Timeframe: At 12 weeks follow-up

Trial details

NCT IDNCT06993831

SponsorMental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-07

View on ClinicalTrials.gov More Schizophrenia Spectrum Disorders trials